Boston Scientific (BSX) 10-K risk factor changes: FY2021 vs FY2020

In addition to the other information contained in this Annual Report [added: on Form 10-K] and the exhibits hereto, the following risk factors should be considered carefully in evaluating our business.

You should refer to the explanation of the qualifications and limitations on forward-looking statements set forth at the end of [removed: Item] [added: *Item] 1.

[removed: Business] [added: Business*] of this Annual [removed: Report.][added: Report on Form 10-K.]

The ongoing global COVID-19 pandemic and related impacts are having [removed: a material] [added: an] adverse effect on our operations, financial performance and cash flows.

Our operations, financial performance and cash flows have been negatively impacted by the ongoing COVID-19 [removed: pandemic that has caused,] [added: pandemic,] and [removed: is expected to continue to cause,] the [removed: global slowdown of economic activity (including] [added: challenging macroeconomic conditions caused by] the [removed: decrease] [added: pandemic, including, but not limited to, disruptions] in [removed: demand for a broad variety of goods and services),] [added: economic activity, including procedures using our products,] disruptions in global supply [removed: chains] [added: chains, labor markets,] and significant [removed: volatility, disruption] [added: volatility in price and availability] of [removed: financial markets, a U.S. economic recession and, potentially, a global economic recession.][added: goods and services.]

Because the severity, magnitude, and duration of the COVID-19 pandemic and its economic consequences are uncertain, rapidly changing, and difficult to predict, the pandemic’s impact on our [added: results of] operations and financial performance, as well as its impact on our ability to execute our business strategies and initiatives successfully, remains uncertain and difficult to predict.

Further, the ultimate impact of the COVID-19 pandemic on our [added: results of] operations and financial performance depends on many factors that are not within our control, including, but not limited, to: governmental, business and individuals’ actions that have been and continue to be taken in response to the pandemic (including restrictions on travel, [added: vaccine mandates,] transport and workforce pressures, and voluntary or mandated deferrals or postponements of elective procedures); the impact of the pandemic and actions taken in response on global and regional economies, travel, and economic activity; the availability of federal, state, local or non-U.S. funding programs; general economic uncertainty in key global markets and financial market volatility; global economic conditions and levels of economic growth; and the timing and pace of recovery when the COVID-19 pandemic subsides, which could be impacted by a number of factors, including limited provider capacity to perform procedures using our products that were deferred as a result of the pandemic.

The COVID-19 pandemic has subjected, and may continue to subject, our [added: results of] operations, financial performance and financial condition to a number of risks, including, but not limited to those discussed below:

- *Operations-related risks*: Across [removed: all of] our businesses, we have faced [removed: increased] operational challenges from the need to protect employee health and safety.

Some of these challenges include site shutdowns, workplace disruptions and restrictions on the movement of people, raw materials and goods, both at our [removed: own] facilities and at customers and [removed: suppliers.][added: suppliers'.]

We also experienced, and may continue experiencing, lower demand and volume for certain products and services, customer requests for [removed: potential] payment deferrals or other contract modifications, delays of deliveries and other factors related directly and indirectly to the COVID-19 pandemic that adversely impact our businesses.

The ability of our employees to work may be significantly impacted by [removed: one or more] employees contracting or being exposed to COVID-19.

Additionally, when [removed: the] economic recovery following the COVID-19 pandemic occurs, we may experience unpredictable increases in demand for certain [removed: of our] products, which could exceed our capacity to meet such demand on a timely basis or at all, which could have a material adverse impact on our [removed: business operations,] financial performance and results of operations.

In certain jurisdictions in the [removed: United States,] [added: U.S.,] governmental authorities have recommended, and in certain cases required, that elective procedures be suspended or canceled to avoid non-essential patient exposure to medical environments and potential [removed: infection with COVID-19 and to focus limited resources and personnel capacity toward the treatment of COVID-19.]

These measures and challenges significantly reduced our net sales and [added: could continue to do so in] the [removed: situation remains challenging.][added: future.]

We believe this [removed: likely] [added: on-going] patient reluctance and potential healthcare provider capacity could [added: continue to] have an adverse effect on our [removed: sales following the end of the pandemic.][added: net sales.]

[removed: However, because the] [added: - *Employee-related risks*: The] severity, magnitude, and duration of the COVID-19 pandemic and its economic consequences are uncertain, rapidly changing, and difficult to predict, [added: and] we [removed: may, in the future,] [added: may] have to [removed: consider taking additional] [added: take] actions [added: to reduce costs and preserve jobs,] including [removed: further] reductions to salary and work hours, [removed: furloughs,] restructuring, layoffs [removed: or extensions of remote work arrangements,] [added: and other measures,] which may negatively impact our workforce and our business.

In particular, the accounting for revenue, inventory, goodwill, intangible assets, income taxes and other assets and liabilities requires reliance on forward looking estimates of sales and/or [removed: earnings.][added: results of operations.]

Changes in the underlying estimates, assumptions or judgments could have a material adverse impact on our future results of [removed: operations,] [added: operations and/or] financial [removed: position and cash flows.][added: position.]

As the COVID-19 pandemic continues to adversely affect our [removed: operating and] [added: results of operations and/or] financial [removed: results,] [added: position,] it may also have the effect of heightening many of the other risks described in the risk factors in this Annual Report on Form 10-K.

Further, the COVID-19 pandemic may also affect our [removed: operating and financial] results [added: of operations and/or financial position] in a manner that is not presently known to us or that we currently do not expect to present significant [removed: risks to our operations or financial results,] [added: risks,] particularly if the COVID-19 pandemic and its associated impacts reoccur in successive [removed: waves in the coming months.][added: waves.]

We also face competition from non-medical device companies, including pharmaceutical [removed: companies,] [added: companies and providers of various diagnostic tests,] which may offer alternative therapies [added: or diagnostics] for disease states also amenable to treatment [added: or diagnosis] using our products.

New competitors may emerge in the future, potentially including companies introducing new sales or distribution models to our industry or leveraging [added: genomic] robotic, navigation, and/or other automation technologies.

There can be no assurance that the size of the markets in which we compete will [removed: increase above existing levels,] [added: increase,] that we will be able to [removed: regain] [added: hold] or gain market share or compete effectively on the basis of price or that the number of procedures in which our products are used will [removed: increase above existing levels.][added: increase.]

Continued consolidation in the healthcare industry or additional governmental controls exerted over pricing [added: and access] in key markets could lead to increased demands for price concessions or limit or eliminate our ability to sell to certain of our significant market segments, which could have an adverse effect on our business, financial condition or results of operations.

[removed: We expect that market demand, government regulation, third-party coverage and reimbursement policies, government contracting requirements and societal pressures will continue to change the worldwide healthcare industry,] resulting in further business consolidations and alliances among our customers, which may increase competition, exert further downward pressure on the prices of our products and services and may adversely impact our business, financial condition or results of operations.

International net sales accounted for 42 percent of our global net sales in [removed: 2020.][added: 2021.]

Further, most countries outside of the U.S. require product approvals be renewed or [removed: recertified] [added: re-certified] on a regular basis in order to continue to be marketed and sold there.

[removed: Global businesses, including those in the] medical device industry, are facing increasing scrutiny of, and heightened enforcement efforts with respect to, their international operations.

If we are unable to manage our debt levels, maintain investment grade credit ratings at the three ratings agencies, or [added: if we] experience a disruption in our cash [removed: flows] [added: flows,] it could have an adverse effect on our cost of borrowing, financial condition or results of operations.

Our outstanding debt balance was [removed: $9.143 billion as of December 31, 2020 and $10.008] [added: $9.065] billion as of December 31, [removed: 2019.][added: 2021.]

[removed: We assess goodwill for impairment at the reporting unit level and, in] [added: In] evaluating the potential for [removed: impairment of goodwill,] [added: impairment,] we make assumptions regarding estimated revenue projections, growth rates, cash flows and discount rates.

Deterioration of the global economy or increase in sovereign debt issues may impact our ability to transfer receivables to third [removed: parties in certain of those countries.]

Third [removed: parties] [added: parties,] such as [removed: banks] [added: banks,] offering factoring programs in these countries are looking to reduce their exposure levels to government owned or supported debt.

In addition, conditions in the financial markets and other factors beyond our control may adversely affect our ability to borrow money in the credit markets, access the capital markets and [removed: to] obtain financing for [added: mergers and] acquisitions [added: (M&A)] or other general [removed: corporate and commercial] purposes.

Our strategic acquisitions, investments and alliances are intended to further expand our ability to offer customers effective, high quality medical [removed: devices that satisfy their interventional needs.][added: devices.]

Strength in the market for IPOs may [added: also] reduce the [removed: set of] opportunities available to us for M&A and/or cause us to need to pay higher prices.

We may not realize the expected benefits from our restructuring and optimization initiatives, our long-term [removed: expense reduction] [added: cost savings] programs may result in an increase in short-term expenses and our efforts may lead to unintended consequences.

We monitor the dynamics of the economy, the healthcare industry and the markets in which we [removed: compete] [added: compete,] and assess opportunities for improved operational effectiveness and efficiency and to better align expenses with revenues, while preserving our ability to make investments in research and development projects, capital and our [removed: people that] [added: people, which] we believe [removed: are] [added: is] important to our long-term success.

As a result of these assessments, we have undertaken restructuring and optimization initiatives [removed: in order] to enhance our growth potential and position us for long-term success.

The considerations and risks that follow are organized within relevant headings but may be relevant to other headings as well.

These conditions and others may persist and worsen, leading to broader economic downturns, including another U.S. and global economic recession.

We are also experiencing increases in prices for, and shortages of, certain parts or components required to manufacture certain of our products.

infection with COVID-19 and to focus limited resources and personnel capacity toward the treatment of COVID-19.

Further, staffing shortages within healthcare facilities, and resulting procedural delays, have and may continue to negatively impact demand for our products.

Additionally, the COVID-19 pandemic has given rise to conditions that have created a highly competitive environment for talent.

Our ability to attract and retain key talent at all levels of our organization has been and could continue to be challenged by these conditions, and inability to attract and retain talent could result in material adverse impacts to our business and results of operations.

In other instances, multinationals may be subject to a separate tender bidding process in which they compete only with each other and not with domestic companies.

Further, in certain markets, the regulatory process through which new medical devices are approved may be faster and/or less burdensome for domestic companies compared to multinationals.

We expect that market demand, government regulation, third-party coverage and reimbursement policies, government contracting requirements and societal pressures will continue to change the worldwide healthcare industry,

Global businesses, including those in the

The US-China relationship will continue to shape the geopolitical stage, with uncertainty created by the change in administration and strategic direction, and difficult political conditions for major actions.

Legislation aimed at boosting competitiveness of U.S. businesses may have unintended effects on our business.

Ultimately, tariffs and other protectionist measures, as well as prolonged uncertainty, may have adverse effects on our ability to source and manufacture products in a timely and cost effective manner, thereby adversely affecting our business.

Lastly, sanctions and export restrictions are expected to proliferate, leading to greater uncertainty in emerging and growth markets.

Notably the Russia-Ukraine crisis is expected to create barriers to doing business in Russia, as well as creating geopolitical shifts in Asia.

We assess goodwill for impairment at the reporting unit level.

We also test our indefinite-lived intangible assets at least annually, or more frequently if impairment indicators are present, and we review intangible assets subject to amortization quarterly for impairment.

parties in certain of those countries.

Some of our competitors in the medical device sector may have access to substantially greater amounts of cash than we do that could be deployed into M&A or strategic investments if they so choose.

In addition, on February 22, 2022, the Company increased and our Board of Directors approved cost estimates to complete additional activities identified under the program.

Under the FDC Act, medical devices must receive FDA

Therefore, there can be no assurance that we will accurately predict the outcomes of these disputes or other tax audits or that issues raised by tax

Additionally, the U.S. Congress has recently been debating changes to U.S. corporate income tax laws, including provisions that may alter the U.S. taxation of the profits of foreign subsidiary corporations.

The OECD/G20 Inclusive Framework (IF) on base erosion and profit shifting (BEPS) includes actions intended to equip governments with domestic and international rules and instruments to address tax avoidance, ensuring that profits are taxed where economic activities generating the profits are performed and where value is created.

The actions include a two-pillar solution to address the tax challenges of the digitalized economy, for which political agreement has been reached among 136 of the 140 members of the IF.

available in order to develop an effective patent strategy, avoid infringement of third-party patents, identify licensing opportunities and monitor the patent claims of others.

Product liability claims, securities and commercial litigation and other litigation in the future, regardless of the

Cyber attacks continue to evolve in complexity and scope, and inherently may be difficult to detect.

We have seen, and could continue to see, vulnerabilities, such as the Log4j vulnerability reported in December 2021, which could affect our systems and the systems of our third-party vendors and business partners.

In addition, such attackers may make demands for ransom, which could result in financial loss, or, if we determine not to pay such ransom, other harm, loss, or misappropriation of our data and assets.

Our business and operations are subject to risks related to climate change.

The effects of global climate change present risks to our business.

Natural disasters, extreme weather and other conditions caused by or related to climate change could adversely impact our supply chain, including manufacturing and distribution networks, the availability and cost of raw materials and components, energy supply, transportation, or other inputs necessary for the operation of our business.

Climate change and natural disasters could also result in physical damage to our facilities as well as those of our suppliers, customers, and other business partners, which could cause disruption in our business and operations or increase costs to operate our business.

Additionally, increased environmental regulation, including to address climate change, may result in increases in our costs to operate our business or restrict certain aspects of our activities.

The extent and severity of climate change impacts are unknown, and therefore, the scope of potential impact on our business may be difficult to predict and it may be difficult to adequately prepare.

Further, the prioritization of vaccine distribution could affect the availability of transportation for our supply chain needs.

In certain jurisdictions, however, the timing of the pandemic and public health measures have resulted in lower levels of COVID-19 cases and some hospitals have developed protocols such that elective procedures may be conducted safely and are approaching pre-COVID-19 pandemic levels.

- *Employee-related risks*: In an attempt to proactively address the changed business environment caused by COVID-19, in order to preserve employees’ jobs and ensure we are able to quickly respond to increased customer demand, when deferrable procedures resume as permitted by development or conclusion of the pandemic, we made temporary work hour reductions, and corresponding salary reductions, where appropriate, for many of our employees.

On January 31, 2020, the United Kingdom (UK) formally exited the European Union (EU), and a transition period began, during which time the U.K. and the EU negotiated a trade agreement and other terms associated with their future relationship.

The transition period ended on December 31, 2020.

The short- and long-term impact of the U.K.’s exit from the EU on European and global macroeconomic conditions, our business operations and results of operations remain unknown.

Changes in industry regulations could have an effect on existing CE certificates being renewed and new certificates being issued which would impact the ability to trade; however, it is impossible to assess the full impact at this stage.

We have implemented a Brexit Response Team and have put in place mitigation procedures intended to reduce any significant operational risks that have been identified to date.

lengthy delays in resuming production of affected products due primarily to needs for regulatory approvals.

The Patient Protection and Affordable Care Act (ACA) and Health Care and Education Affordability Reconciliation Act of 2010 were enacted into law in the U.S. in March 2010.

Certain provisions of this law, including comparative effectiveness research, pilot programs to evaluate alternative payment methodologies and other changes to the payment systems, have started changing the way healthcare is delivered, reimbursed and funded.

While the extent to which it has affected our business is not clear, these changes, over the long-term, may adversely affect our business and results of operations.

The new U.S. Administration may attempt to reverse some of the previous Administration’s changes to the ACA, particularly related to healthcare coverage for the uninsured, and is further expected to introduce more ambitious healthcare legislation, which could include what is commonly referred to as a “public option” or changes to Medicare age requirements.

If passed, this legislation would lead to increased coverage levels and utilization of services; however, at this point, the impact of any such changes is unclear because specific changes have not been enacted or implemented.

The OECD has released its comprehensive plan to create an agreed set of international rules for fighting base erosion and profit shifting.

In the European

The following discussion and analysis provides information management believes to be relevant to understanding the financial condition and results of operations of Boston Scientific Corporation and its subsidiaries for the years ended December 31, [removed: 2020] [added: 2021] and [removed: 2019.][added: 2020.]

Financial Statements and Supplementary Data of this Annual [removed: Report.][added: Report on Form 10-K.]

For additional information on our financial condition and results of operations for the year ended December 31, [removed: 2018,] [added: 2019,] refer to our previously filed Annual Report on Form 10-K.

In March 2020, the World Health Organization [removed: (WHO)] declared COVID-19, including all additional variations and strains thereof, a global pandemic (COVID-19 pandemic).

As the pandemic spread [removed: worldwide and with COVID-19 cases confirmed in all major geographies,] [added: worldwide,] many elective and semi-emergent procedures [removed: were] [added: have been] postponed, [added: particularly during the second half of 2020 and first half of 2021,] enabling hospital staff to focus critical resources on caring for COVID-19 patients.

We also implemented a temporary four-day work week for many employees globally and reduced employee [removed: compensation, including temporary significant cuts in the salaries of our executive officers and the cash retainer paid to our Board of Directors.][added: compensation.]

Because the severity, magnitude, and duration of the COVID-19 pandemic and its economic consequences [removed: are uncertain and rapidly changing,] [added: continue to be uncertain,] the pandemic’s impact on our operations and financial performance, as well as its impact on our ability to [added: execute our business strategies and initiatives successfully, remains uncertain and difficult to predict.]

Procedural delays from the further resurgence of COVID-19 infections and the emergence of new, more contagious variant strains of [removed: COVID-19] [added: COVID-19, as well as staffing shortages within healthcare facilities, have and] may continue to negatively impact demand for our products, net sales, gross profit margin and operating expenses as a percentage of net [removed: sales in 2021.][added: sales.]

Since the onset of [removed: COVID-19,] [added: the COVID-19 pandemic,] our global crisis management team has focused on protecting our employees and customers, optimizing our operations and securing our supply chain.

We have successfully implemented business continuity plans including establishing a medical advisory group for employees, leveraging work from home infrastructure to facilitate social [removed: distancing, limiting sales visits to critical cases] [added: distancing] and accelerating capabilities to provide remote physician support.

While we expect the COVID-19 pandemic will continue to negatively impact our [removed: 2021 performance,] [added: performance to an extent,] we continue to believe our long-term fundamentals remain strong and we will manage through these challenges with strategic focus and the winning spirit of our global team.

[removed: This decrease of $823 million, or 7.7 percent, included operational declines of 7.8 percent and the positive impact of 10 basis points from foreign currency fluctuations.1] Operational net sales included $413 million in 2020 associated with our acquisition of Vertiflex, Inc. (Vertiflex) for the period prior to June 2020 and our acquisition of BTG plc (BTG) for the period prior to mid-August 2020, for both of which there were no prior period net sales.

Excluding these items, adjusted net income [removed: available to common stockholders] for 2020 was $1.378 billion, or $0.96 per diluted [removed: share.][added: share.1,2]

Our reported net income [added: available to common stockholders] in [removed: 2019] [added: 2021] was [removed: $4.700 billion,] [added: $985 million,] or [removed: $3.33] [added: $0.69] per diluted share.

Our reported results for [removed: 2019] [added: 2021] included certain charges and/or credits totaling [removed: $2.466] [added: $1.351] billion (after-tax), or [removed: $1.75] [added: $0.94] per diluted share.

Excluding these items, adjusted net income [added: available to common stockholders] for [removed: 2019] [added: 2021] was [removed: $2.234] [added: $2.336] billion, or [removed: $1.58] [added: $1.63] per diluted [removed: share.1][added: share.1,2]

| | | | Year Ended December 31, 2020 | | | | | | | | | [added: | | | | | | | | |]

| Non-GAAP adjustments: | | | | | | | | | | | | [added: | | | | | | | | |]

| Amortization expense | | | [added: 789 | | | (88) | | |] 701 | | | [added: —] | | | [added: 701 | | |] 0.49 | | |

| Goodwill and other intangible asset impairment charges | | | [added: 533 | | | (68) | | |] 465 | | | [added: —] | | | [added: 465 | | |] 0.32 | | |

| Acquisition/divestiture-related net charges (credits) | | | [added: 196 | | | (81) | | |] 115 | | | [added: —] | | | [added: 115 | | |] 0.08 | | |

| Restructuring and restructuring-related net charges (credits) | | | [added: 171 | | | (25) | | |] 146 | | | [added: —] | | | [added: 146 | | |] 0.10 | | |

| Litigation-related net charges (credits) | | | [added: 278 | | | (17) | | |] 261 | | | [added: —] | | | [added: 261 | | |] 0.18 | | |

| Investment portfolio net losses (gains) | | | [added: (429) | | | 98 | | |] (331) | | | [added: —] | | | [added: (331) | | |] (0.23) | | |

| [removed: EU MDR] [added: European Union (EU) Medical device regulation (MDR)] implementation costs | | | [added: 29 | | | (3) | | |] 25 | | | [added: —] | | | [added: 25 | | |] 0.02 | | |

| Deferred tax expenses (benefits) | | | [added: — | | |] 41 | | | [added: 41] | | | [added: — | | | 41 | | |] 0.03 | | |

| Discrete tax items | | | [added: — | | |] 69 | | | [added: 69] | | | [added: — | | | 69 | | |] 0.05 | | |

[removed: (3)] [added: (4)] For 2020, the effect of assuming the conversion of MCPS into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS.

Accordingly, GAAP *Net [removed: loss*] [added: income (loss)*] and Adjusted net income were reduced by cumulative *Preferred stock dividends*, as presented in our consolidated statements of operations, for purposes of calculating GAAP *Net [removed: loss] [added: income (loss)] available to common stockholders*.

| | | | Year Ended December 31, [removed: 2019] [added: 2021] | | | | | | | | | [added: | | | | | | | | |]

| Non-GAAP adjustments: | | | | | | | | | | | | [added: | | | | | | | | |]

| Intangible asset impairment charges | | | [removed: 102] [added: 370] | | | | | | [removed: 0.07] [added: 460] | | | [added: | | | 105 | | |]

| Acquisition/divestiture-related net charges (credits) | | | [removed: 672] [added: (450)] | | | [added: (2)] | | | [removed: 0.48] [added: (453)] | | | [added: — | | | (453) | | | (0.32) | | |]

| Restructuring and restructuring-related net charges (credits) | | | [removed: 68] [added: 191] | | | [added: (22)] | | | [removed: 0.05] [added: 169] | | | [added: — | | | 169 | | | 0.12 | | |]

| Litigation-related net charges (credits) | | | [removed: 72] [added: 430] | | | [added: (98)] | | | [removed: 0.05] [added: 331] | | | [added: — | | | 331 | | | 0.23 | | |]

| Investment portfolio net losses (gains) | | | [removed: 3] [added: 181] | | | [added: (43)] | | | [removed: 0.00] [added: 137] | | | [added: — | | | 137 | | | 0.10 | | |]

| Deferred tax expenses (benefits) | | | [removed: (4,102)] [added: —] | | | [added: 132] | | | [removed: (2.91)] [added: 132] | | | [added: — | | | 132 | | | 0.09 | | |]

| Discrete tax items | | | [removed: 18] [added: —] | | | [added: (5)] | | | [removed: 0.01] [added: (5)] | | | [added: — | | | (5) | | | (0.00) | | |]

Business* of this Annual [removed: Report.][added: Report on Form 10-K.]

Our net sales of Endoscopy products of [removed: $1.780] [added: $2.141] billion represented 18 percent of our consolidated net sales in [removed: 2020.][added: 2021.]

In addition, conditions created by the COVID-19 pandemic, the economic recovery that has followed in many areas and other macroeconomic factors have led to a challenging labor market in which we compete, which affects our ability to retain and attract new talent as well as put inflationary pressure on certain operational costs due to wage increases.

Further, we face and may continue to face, increases in the cost and limited availability of raw materials, components, and other inputs necessary to manufacture and distribute our products due to constraints within the global supply chain, as well as increases in the cost and time to distribute our products.

We will continue to be guided by our values and mission and monitor our return-to-office strategy based on science and data for the health and safety of our employees.

In 2021, we generated net sales of $11.888 billion, as compared to $9.913 billion in 2020.

This increase of $1.975 billion, or 19.9 percent, included operational growth of 18.7 percent and the positive impact of 130 basis points from foreign currency fluctuations.1 Operational net sales included $212 million in 2021 associated with our acquisitions of Preventice Solutions, Inc. (Preventice), Farapulse, Inc. (Farapulse) and the global surgical business of Lumenis, LTD (Lumenis), for which there were no prior period net sales.

Operational net sales also included $202 million in 2020 associated with our intrauterine health franchise and the Specialty Pharmaceuticals business, divested in the second quarter of 2020 and first quarter of 2021, respectively.

The increase in our net sales was primarily driven by the recovery of elective and semi-emergent procedure volumes compared to the prior year when the COVID-19 pandemic had a more significant impact on our net sales.

| *(in millions, except per share data)* | | | Income (Loss) Before Income Taxes | | | Income Tax Expense (Benefit) | | | Net Income (Loss) | | | Preferred Stock Dividends | | | Net Income (Loss) Available to Common Stockholders | | | Impact per Share(3) | | |

| Reported | | | $ | 1,076 | | $ | 36 | | $ | 1,041 | | $ | (55) | | $ | 985 | | $ | 0.69 | |

| Amortization expense | | | 741 | | | (65) | | | 676 | | | — | | | 676 | | | 0.47 | | |

| Goodwill and other intangible asset impairment charges | | | 370 | | | (51) | | | 318 | | | — | | | 318 | | | 0.22 | | |

| European Union (EU) Medical device regulation (MDR) implementation costs | | | 49 | | | (4) | | | 45 | | | — | | | 45 | | | 0.03 | | |

| Adjusted | | | $ | 2,587 | | $ | 196 | | $ | 2,391 | | $ | (55) | | $ | 2,336 | | $ | 1.63 | |

(3) For 2021, the effect of assuming the conversion of MCPS into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS.

| *(in millions, except per share data)* | | | Income (Loss) Before Income Taxes | | | Income Tax Expense (Benefit) | | | Net Income (Loss) | | | Preferred Stock Dividends | | | Net Income (Loss) Available to Common Stockholders | | | Impact per Share(4) | | |

| Reported | | | $ | (79) | | $ | 2 | | $ | (82) | | $ | (33) | | $ | (115) | | $ | (0.08) | |

| Adjusted | | | $ | 1,488 | | $ | 77 | | $ | 1,411 | | $ | (33) | | $ | 1,378 | | 0.96 | | |

Accordingly, GAAP *Net income (loss)* and Adjusted net income were reduced by cumulative *Preferred stock dividends*, as presented in our consolidated statements of operations, for purposes of calculating GAAP *Net income (loss) available to common stockholders*.

These year-over-year changes were primarily driven by our biliary, single-use imaging, hemostasis and infection prevention franchises due to the recovery of elective and semi-emergent procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales.

Operational net sales growth included organic net sales growth of 19.2 percent in 2021 and the net positive impact of 280 basis points due to our Lumenis, LTD. (Lumenis) acquisition less the impact of the divestiture of the Intrauterine Health business in the second quarter of 2020.

In the third quarter of 2021, we completed the acquisition of the global surgical business of Lumenis, a privately-held company that develops and commercializes energy-based medical solutions, including innovative laser systems, fibers and accessories used for urology and otolaryngology procedures.

Organic net sales growth was driven by our stone management and prostate health franchises and prosthetic urology franchise due to the recovery of elective and semi-emergent procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales.

Operational net sales growth included organic net sales growth of 7.7 percent in 2021 and the positive impact of 950 basis points from the acquisition of Preventice Solutions, adding to our CRM business a full portfolio of mobile cardiac health solutions and services, ranging from ambulatory cardiac monitors, to cardiac event monitors and mobile cardiac telemetry.

Organic sales growth was attributable to our defibrillator and pacemaker franchises, due to the recovery of semi-emergent and emergent procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales, as well as our cardiac diagnostics franchise, led by our ICM system.

This increase included operational net sales growth of 25.8 percent and the positive impact of 160

basis points from foreign currency fluctuations, as compared to 2020.

Operational net sales growth was primarily driven by the recovery of elective procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales, as well as the success of our ongoing POLARx™ Cryoablation System and Stablepoint Force-Sensing Catheter international launches in Europe and Japan.

Neuromodulation net sales increased $148 million, or 19.5 percent, in 2021, as compared to 2020.

Operational net sales growth was primarily driven by our spinal cord stimulation (SCS) systems, led by our next generation WaveWriter Alpha™ SCS System and our deep brain stimulation (DBS) systems, including our Vercise Genus™ DBS System, due to the recovery of elective procedure volumes in the first half of 2021 compared to the prior year when the COVID-19 pandemic had a more significant negative impact on our net sales.

During the second half of 2021, procedure volumes continued to be negatively impacted by the COVID-19 pandemic due to their elective nature.

Operational net sales growth was driven by our WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device, our percutaneous coronary intervention guidance (PCIG) franchise, our complex PCI product offerings, and our drug-eluting stent (DES) systems due to the recovery of procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales.

In addition, growth was positively impacted by $179 million in reserves recorded in the second half of 2020 primarily related to our conversion to a consignment inventory model for our LAAC franchise with the launch of our WATCHMAN FLX™ Device in the U.S. These increases were partially offset by the discontinuation of our LOTUS Edge™ Aortic Value System in the fourth quarter of 2020, general price declines associated with our DES systems and the unfavorable impact of China tender pricing on both DES systems and balloon catheter net sales following a reduction in prices in the first quarter of 2021.

Operational net sales growth was primarily driven by the Interventional Oncology franchise, including our TheraSphere™ Y-90 Radioactive Glass Microspheres, which received U.S. Food and Drug Administration approval in the first quarter of 2021 after 20 years as a humanitarian exemption (HDE) device.

In addition, growth was driven by our drug-eluting portfolio, including the Eluvia™ Drug-Eluting Stent and Ranger™ Drug-Coated Balloon due to the recovery of procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales, as well as continued worldwide commercial execution and adoption in recently approved countries.

In the first quarter of 2021, we received approval from Japan's Ministry of Health, Labor and Welfare (MHLW) for Ranger™ and initiated a full launch.

On March 1, 2021, we completed the divestiture of the Specialty Pharmaceuticals business for a purchase price of approximately $800 million.

Our consolidated net sales include Specialty Pharmaceuticals up to the date of the closing of the transaction.

We have revised prior period amounts to conform to the current year's presentation.

Operational net sales growth was driven primarily by our net sales in China, which have largely recovered from the impact of the COVID-19 pandemic on procedural volumes.

(5) On March 1, 2021, we completed the divestiture of the Specialty Pharmaceuticals business.

Some jurisdictions mandated elective procedure bans that included financial penalties for non-compliance, certain of which continued to be in effect throughout the year, or evolved to reduce capacity available for elective procedures, including in some cases restricting elective procedures to those that are outpatient procedures only.

In other jurisdictions, the timing of the pandemic and public health measures resulted in lower levels of COVID-19 cases, while hospitals developed protocols such that elective procedures could be conducted safely.

The ongoing pandemic and accompanying restrictions negatively impacted our net sales and our results of operations in 2020.

We experienced some improvement in our global sales trends in the second half of 2020 as previously deferred procedures resumed and referral rates improved.

However, as COVID-19 cases re-surged in many locations around the world and new, more contagious variant strains of COVID-19 emerged in late 2020, renewed restrictions were implemented in areas that had previously reopened, including in parts of Europe and the U.S. In the fourth quarter of 2020, the U.S. Food and Drug Administration (FDA) issued emergency use authorizations for two COVID-19 vaccines and regulatory bodies in other geographies around the world have also authorized COVID-19 vaccines for use.

The timing and success of efforts to distribute and administer these vaccines to broad portions of the population, enabling widespread immunity to COVID-19, will impact the duration and extent of the pandemic and its effect on demand for our products.

In response to the COVID-19 pandemic, we implemented cost reduction initiatives, including decreases in travel, meetings and customer events, hiring, clinical programs and certain research and development projects.

In addition, we temporarily closed and/or reduced production levels at certain of our manufacturing sites in an effort to align our build plans to the current and expected demand environment.

As COVID-19 cases began to decrease in certain geographies mid-year, we implemented a careful and tiered approach for employees to return to our sites following state and local ordinances, and continue to adjust for the recent resurgence in COVID-19 cases, including outbreaks of new variants of the disease.

Employees with the greatest need to access onsite resources to perform their roles have returned first, while those who can effectively work remotely will continue to do so in order to facilitate maximum social distancing in our sites and within our communities.

For non-executive officer employees, in those jurisdictions where temporary four-day work weeks and reductions in employee compensation were in effect, those measures concluded at the beginning of the third quarter.

We also announced the end of the aforementioned reductions in executive officer pay and further announced that a portion of the annual cash retainer for our Board of Directors would be restored, beginning with a payment made during the fourth quarter of 2020.

While we have implemented measures to reduce costs, our operating expenses as a percentage of net sales increased during 2020, as compared to the prior year, as approximately 70 percent of our operating expenses are fixed in nature.

Our gross profit margin was also unfavorably impacted by the COVID-19 pandemic, due primarily to manufacturing costs associated with abnormally low production levels in our plants.

All of our plants have now resumed manufacturing and have returned to more normalized production levels exiting 2020.

execute our business strategies and initiatives successfully, remains uncertain and difficult to predict.

We have evaluated the recoverability of the assets in our consolidated balance sheet in accordance with relevant authoritative accounting literature.

We considered the disruptions caused by COVID-19, including revised forecasted sales and customer demand, a decline in the price of our common stock and macroeconomic factors potentially impacting accounts receivable, inventory, investments, intangible assets, goodwill and other assets and liabilities.

Where forward-looking estimates are required, we made a good-faith estimate based on information available as of the balance sheet date.

We have continued to monitor for indicators of impairment through the date of this Annual Report filed on Form 10-K, and reflected accordingly in the accompanying consolidated financial statements.

1,2

| | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| *(in millions, except per share data)* | | | Earnings | | | | | | Impact per Share(3) | | |

| Reported Net income (loss) | | | $ | (82) | | | | | | | |

| Reported Preferred stock dividends | | | (33) | | | | | | | | |

| Reported Net income (loss) available to common stockholders | | | $ | (115) | | | | | $ | (0.08) | |

| | | | | | | | | | | | |

| Adjusted net income (loss) available to common stockholders | | | $ | 1,378 | | | | | $ | 0.96 | |

| | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| *(in millions, except per share data)* | | | Earnings | | | | | | Impact per Share | | |

| Reported Net income (loss) | | | $ | 4,700 | | | | | $ | 3.33 | |

| Amortization expense | | | 628 | | | | | | 0.44 | | |

| EU MDR implementation costs | | | 5 | | | | | | 0.00 | | |

| Debt extinguishment net charges (credits) | | | 67 | | | | | | 0.05 | | |

| Adjusted net income (loss) | | | $ | 2,234 | | | | | 1.58 | | |

*Cash provided by operating activities* was $1.508 billion in 2020.

As of December 31, 2020, we had total debt of $9.143 billion, *Cash and cash equivalents* of $1.734 billion and working capital of $3.013 billion.

Refer to *Liquidity and Capital Resources* for further information.

We had currency derivative instruments outstanding in the contract amount of [removed: $10.481] [added: $8.381] billion as of December 31, [removed: 2020] [added: 2021] and [removed: $9.221] [added: $10.481] billion as of December 31, [removed: 2019.][added: 2020.]

A ten percent appreciation in the U.S. dollar’s value relative to the hedged currencies would increase the derivative instruments’ fair value by [removed: $333] [added: $298] million as of December 31, [removed: 2020] [added: 2021] as compared to [removed: $337] [added: $333] million as of December 31, [removed: 2019.][added: 2020.]

A ten percent depreciation in the U.S. dollar’s value relative to the hedged currencies would decrease the derivative instruments’ fair value by [removed: $407] [added: $364] million as of December 31, [removed: 2020] [added: 2021] as compared to [removed: $412] [added: $407] million as of December 31, [removed: 2019.][added: 2020.]

Our interest rate risk relates primarily to U.S. dollar [added: and euro-denominated] borrowings partially offset by U.S. dollar cash investments.

We had no interest rate derivative instruments outstanding as of December 31, [removed: 2020] [added: 2021] and December 31, [removed: 2019.][added: 2020.]

As of December 31, [removed: 2020, $9.205] [added: 2021, $9.121] billion in aggregate principal amount of our outstanding debt obligations were at fixed interest rates, representing approximately 100 percent of our total debt, on an amortized cost basis.

As of December 31, [removed: 2020,] [added: 2021,] our outstanding debt obligations at fixed interest rates were comprised of senior notes.

Financial Statements and Supplementary Data of this Annual Report [added: on Form 10-K] for further information regarding our derivative financial instruments.

We have audited the accompanying consolidated balance sheets of Boston Scientific Corporation (the Company) as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] the related consolidated statements of operations, comprehensive income (loss), stockholders' equity and cash flows for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] and the related notes and financial statement schedule listed in the Index at Item 15(a) (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 23, [removed: 2021] [added: 2022] expressed an unqualified opinion thereon.

| *Description of the Matter* | | | [removed: Contingent Consideration] [added: Business Combinations] | | |

| As disclosed in Note B to the consolidated financial statements, [added: during 2021,] the Company [added: completed four acquisitions for total aggregate purchase price of $3.3 billion, net of cash acquired. The transactions were accounted for as business combinations. In certain acquisitions, the Company] has recognized a liability for acquisition consideration that is contingent upon achieving either research and [removed: development and commercialization milestones,] [added: development, commercialization,] or sales-based milestones. The Company determines the fair value of these [added: contingent consideration] arrangements, both as part of the initial purchase price allocation, and on an ongoing basis each reporting period until the arrangements are settled. [removed: Subsequent changes to the fair value of the contingent consideration liabilities are recorded within the consolidated statement of earnings in the period of change.] As of December 31, [removed: 2020,] [added: 2021,] the amount accrued for future estimated contingent consideration is [removed: $196 million] [added: $486 million,] which represents a Level 3 estimate in the fair value hierarchy due to the significant unobservable inputs used in determining the fair value and the use of management judgment about the assumptions [added: that] market participants would use in pricing the liabilities. [added: Auditing the Company’s accounting for its acquisitions was complex due to the significant estimation required by management to determine the fair value of identified intangible assets, which totaled $1.2 billion and principally consisted of developed technology, and to determine the fair value of contingent consideration arrangements. A significant emphasis is placed on the appropriateness of the estimates used by management to determine the fair value of acquired intangible assets due to the sensitivity of the respective fair values to the underlying assumptions.] The [added: Company used an income approach to measure the technology-related intangible assets. The significant assumptions used to estimate the value of the intangible assets included discount rates and certain assumptions that form the basis of the forecasted results, including revenue growth rates, estimates of technological obsolescence, operating profit margin and market participant synergies. The] significance of the estimations used by management to determine the fair value of contingent consideration was primarily due to the sensitivity of the respective fair values to the [removed: significant] underlying assumptions. The significant assumptions include estimation of the probability and timing of payment, future sales forecasts, as well as the appropriate discount rate based on the estimated timing of payments. These significant assumptions are forward looking and could be affected by future economic and market conditions. | | | | | |

| *How We Addressed the Matter in Our Audit* | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s accounting for [added: acquisitions. For example, we tested controls over] the [added: identification and] valuation of [added: intangible assets, including] the [added: valuation models and underlying assumptions used to develop such estimates. We also tested controls over the valuation of the] contingent consideration [removed: liabilities,] [added: liability,] including the valuation models and underlying assumptions used to develop such estimates. [added: For each of the Company's acquisitions, we read the purchase agreements, evaluated the significant assumptions and methods used in developing the fair value estimates, and tested the recognition of (1) the tangible assets acquired and liabilities assumed at fair value; (2) the identifiable intangible assets acquired at fair value; and (3) goodwill measured as a residual. To test the estimated fair value of the intangible assets, we performed audit procedures that included, among others, evaluating the Company's use of the income approach and testing the significant assumptions used in the model, as described above.] In testing the valuation of contingent consideration, we assessed, among other things, the terms of the arrangements and the conditions that must be met for the [removed: arrangements] [added: amounts] to become payable. We evaluated the completeness and accuracy of the underlying data used in the analyses. For example, we compared the significant assumptions [removed: such as revenue growth rates] to current industry, market and economic trends, to the assumptions used to value similar assets in other [removed: acquisitions when relevant, and] [added: acquisitions,] to the historical results of the acquired business [removed: where available.] [added: and to other guideline companies within the same industry.] We involved our valuation professionals to assist with our evaluation of the methodology used by the Company and significant assumptions included in the fair value estimates. | | |

February 23, 2022

February 23, 2021

We have also accelerated the development of [removed: our] digital [removed: capabilities in multiple key areas, which helps] [added: tools and technologies to] enable us to compete more effectively in the current healthcare [removed: environment] [added: environment,] where our customers are looking for ways to improve outcomes and lower [removed: costs.][added: costs, and to make it easier to do business with Boston Scientific across multiple sites of care.]

Our Board of Directors oversees our risk management program and focuses on monitoring, [removed: and] [added: and,] together with management, mitigating the most significant risks facing the Company, including strategic, operational, [added: reputational,] financial, legal and compliance risks.

This includes taking actions to combat discrimination and advancing equality and diversity, including through financial support of racial equity initiatives in the communities where we live and work, [removed: supporting COVID-19 relief efforts,] protecting the environment, investing in our employees' health and well-being, and many other initiatives that ultimately help us create value responsibly.

Our [removed: seven] core businesses are organized into three reportable segments: MedSurg, Rhythm and Neuro, and Cardiovascular.

- [removed: our] Resolution 360™ [removed: Clip, a] [added: Clips and Resolution 360™ ULTRA Clips,] hemostatic clipping technology designed to stop and help prevent bleeding during endoscopic procedures,

- [removed: Our] WallFlex™ Biliary Stent [removed: System,] [added: Systems,] used for relieving biliary [removed: obstruction] [added: obstructions] by providing bile drainage in both malignant and benign strictures,

- [removed: our] AXIOS™ [removed: Stent] [added: Stents] and Electrocautery Enhanced Delivery [removed: System,] [added: Systems,] the first, and currently only [removed: stent] [added: stents] in the U.S. indicated for endoscopic drainage of pancreatic pseudocysts,

- [removed: our] SpyGlass™ DS II Direct Visualization [removed: System,] [added: Systems,] which [removed: brings] [added: bring] digital imaging, a wider field of view and a simpler set-up (compared to our legacy SpyGlass System), thus enabling cholangioscopy to play a greater role in the diagnosis and treatment of pancreatico-biliary diseases,

- [removed: our] SpyGlass™ Discover Digital [removed: Catheter,] [added: Catheters,] the first single-use [removed: scope] [added: scopes] to enable physicians to take a single-stage approach to diagnostic and therapeutic procedures in the pancreaticobiliary system, including treating patients with bile duct stones,

- [removed: our] EXALT™ Model D Single-Use [removed: Duodenoscope] [added: Duodenoscopes] for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures, the first [removed: and only] U.S. Food and Drug Administration (FDA)-cleared single-use (disposable) [removed: duodenoscope] [added: duodenoscopes] on the market,

- [removed: our] Acquire™ Endoscopic Ultrasound Fine Needle Biopsy [removed: Device,] [added: Devices,] which [removed: is] [added: are] designed to obtain larger tissue specimens for histological assessment and [removed: is] [added: are] useful when diagnosing diseases such as pancreatic cancer, liver cancer and stomach lesions,

- our endoluminal surgery portfolio [removed: with] [added: featuring] ORISE™ [removed: Gel,] [added: Gel and ORISE™ ProKnife,] designed to be used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or other endoscopic device, and

- [removed: our] [added: a] comprehensive line of stone management products, including ureteral stents, catheters, baskets, guidewires, sheaths, balloons and stone laser devices,

- [removed: our] LithoVue™ Single-Use Digital Flexible [removed: Ureteroscope,] [added: Ureteroscopes,] which [removed: delivers] [added: deliver] detailed high-resolution digital images for high-quality visualization and seamless navigation,

- [removed: our] BPH [removed: therapies portfolio,] [added: therapies,] which [removed: includes] [added: include] our GreenLight XPS™ Laser System, MoXy™ Fiber, and Rezūm™ System, [removed: purchased as part of the NxThera, Inc. (NxThera) acquisition in the second quarter of 2018, and]

- [removed: our] implantable cardioverter defibrillators (ICD) and implantable cardiac resynchronization therapy defibrillators (CRT-D) as well as the world's first, and currently only, commercially available subcutaneous implantable cardiac defibrillators (S-ICD),

- [removed: our] pacemakers and implantable cardiac resynchronization therapy pacemakers (CRT-P), [removed: and]

- [removed: our] LATITUDE™ Remote Patient Management [removed: System,] [added: Systems,] which [removed: allows] [added: allow] for more frequent monitoring and better guided treatment decisions by enabling physicians to monitor implantable system performance remotely [removed: in most geographies.][added: and]

[removed: In June 2020, we announced U.S. 510(k) clearance for the] [added: -] LUX-Dx™ Insertable Cardiac Monitor (ICM) [removed: system, a] [added: systems,] new, long-term diagnostic [removed: device] [added: devices] implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.

[added: In addition, in the first quarter of 2021, we completed the acquisition of] Preventice [added: Solutions, Inc., a privately-held company that] offers a full portfolio [added: of mobile health solutions and remote monitoring services,] ranging from ambulatory cardiac monitors – including short and long-term holter monitors – to cardiac event monitors and mobile cardiac telemetry, complementing our existing ICM offering.

Our entire transvenous defibrillator portfolio leverages our EnduraLife™ Battery Technology, including our extended longevity [removed: (EL)] ICD, our CRT-D’s and our [removed: MINI (smallest] [added: smallest] and [removed: thinnest)] [added: thinnest MINI] ICD.

We have magnetic resonance imaging (MRI) conditional labeling across our defibrillator portfolio [removed: in nearly all markets] around the world when used with our current generation of leads, including our current generation devices as well as our prior generation of DYNAGEN™ and INOGEN™ devices.

- [removed: our] Rhythmia™ Mapping [removed: System, a] [added: Systems,] catheter-based, 3-D cardiac mapping and navigation [removed: solution] [added: solutions] designed to help diagnose and guide treatment of a variety of arrhythmias,

- [removed: our] Blazer™ Therapeutic Ablation [removed: Catheter line,][added: Catheters,]

- [removed: our] IntellaMap OrionTM Mapping [removed: Catheter,] [added: Catheters,] for use with our Rhythmia Mapping System to provide high-density, high-resolution maps of the heart, [removed: and]

- [removed: our] intracardiac ultrasound catheters, delivery sheaths and other accessories.

[removed: All] [added: Certain] of our IntellaNav Catheters [added: include MicroFidelity (MiFi) sensor technology in the catheter tip, and all] are designed to allow magnetic tracking when used with our Rhythmia Mapping System.

[removed: DIRECTSENSE Software provides] [added: Additionally, all major markets have access to our DIRECTSENSE™ Software, a tool for monitoring radiofrequency (RF) energy delivery during cardiac ablation procedures, providing] meaningful information on tissue to catheter tip proximity, catheter stability, and other local tissue characteristics.

- [removed: our] Precision™, Precision Spectra™, Precision Montage™, Precision [removed: Novi™ and] [added: Novi™,] Spectra WaveWriter™ [added: and WaveWriter Alpha™] Spinal Cord Stimulator (SCS) Systems, designed to provide improved pain relief to a wide range of patients who suffer from chronic pain,

- [removed: our] Superion™ Indirect Decompression [removed: System, a] [added: Systems,] minimally-invasive [removed: device] [added: devices] used to improve physical function and reduce pain in patients with [added: moderate] lumbar spinal stenosis (LSS) purchased as part of the acquisition of Vertiflex, Inc. in the second quarter of 2019,

- our G4™ Generator and consumable portfolio in Radiofrequency Ablation (RFA) for pain management used by physicians to treat patients with chronic [removed: back and neck pain purchased as part of the acquisition of Cosman Medical, Inc. in the third quarter of 2016,] [added: pain,] and

- [removed: our] Vercise™, Vercise™ [removed: PC and] [added: PC,] Vercise Gevia™ [added: and Vercise Genus™] Deep Brain Stimulation (DBS) Systems for the treatment of Parkinson's disease, tremor, and intractable primary and secondary dystonia, a neurological movement disorder characterized by involuntary muscle contractions.

Our Spectra WaveWriter™ SCS System is the first [removed: and only] system approved by the FDA to simultaneously provide paresthesia-based and sub-perception therapy.

We announced the European launch of the WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System in the third quarter of 2020 and [added: received] FDA approval in the fourth quarter of [removed: 2020,] [added: 2020 and followed with U.S. launch,] indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with failed back surgery [added: syndrome and complex regional pain] syndrome.

Our Vercise™ DBS [removed: System is] [added: Systems are] approved in the U.S. as an adjunctive therapy that aids in reducing some of the symptoms of moderate to advanced Parkinson’s [removed: disease.][added: disease as well as for patients diagnosed with essential tremor.]

[removed: Our] [added: The] Vercise [removed: Gevia™] [added: Genus™] DBS [removed: System] [added: platform features a full portfolio of primary cell and rechargeable MRI conditional systems] with [added: Bluetooth connectivity and] the Cartesia™ Directional [removed: Lead is the first and only MRI conditional, rechargeable and directional system, using] [added: Lead, providing] multi-directional stimulation designed for greater precision, intended to minimize side effects for [removed: patients, having ImageReady™ MRI labeling to be used in a full-body magnetic resonance imaging environment.][added: patients.]

In the third quarter of 2020, we received CE Mark and initiated a limited market release of the fourth generation Vercise Genus™ DBS System in [removed: Europe.][added: Europe, and launched in the U.S in the first quarter of 2021, following FDA approval.]

- [removed: our] [added: SYNERGY™, SYNERGY MEGATRON™ and] SYNERGY™ [added: XD] Everolimus-Eluting Platinum Chromium Coronary Stent [removed: System,] [added: Systems,] featuring an ultra-thin abluminal (outer) bioabsorbable polymer [removed: coating,][added: coating and]

- [removed: our] Promus ELITE™ [added: and Promus PREMIER™] Everolimus-Eluting [removed: Stent,][added: Stent Systems.]

- [removed: our] OptiCross™ IVUS Imaging [removed: catheter,][added: Catheters,]

Specifically, we are scaling our digital capabilities to deliver first class physician education, drive deeper patient engagement and increase digitally-enabled sales force productivity.

Refer to discussion of *Community Outreach* below and *Corporate Sustainability* included in Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations of this Annual Report on Form 10-K for additional information regarding measures we are undertaking.

- EXALT™ Model B Single-Use Bronchoscopes for use in a wide range of bronchoscopy procedures in the intensive care unit (ICU) and operating room (OR), such as secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal tube placement and biopsies,

During 2021, we launched our next-generation Resolution 360™ ULTRA Clip, featuring increased jaw length, thickness and volume capacity, and currently the largest through-the-scope hemostasis clip on the market, designed to approximate greater amount of tissue and facilitate stronger closing strength.

- SpaceOAR™ Hydrogel Systems which help reduce side effects that men may experience after receiving radiotherapy to treat prostate cancer, and our SpaceOAR Vue™ Hydrogel, providing clinicians with enhanced product visualization using computerized tomography (CT) scans instead of magnetic resonance imaging (MRI), and

In the third quarter of 2021, we completed the acquisition of the global surgical business of Lumenis LTD (Lumenis), a privately-held company that develops and commercializes energy-based medical solutions, including innovative laser systems, fibers and accessories used for urology and otolaryngology procedures.

- POLARxTM Cryoablation single shot ablation systems, and

We also offer our IntellaNav XP and IntellaNav MiFi XP solid tip catheters, as well as the CE Mark and Japanese Pharmaceuticals and Medical Device Agency (PMDA) approved IntellaNav STABLEPOINTTM Ablation Catheter.

In the second half of 2021, we received Japanese PMDA approval and commenced the Japanese launch of our POLARxTM Cryoablation Single-shot Pulmonary Vein Isolation Technology.

During 2021, we completed enrollment in the FROZEN-AF investigational device exemption (IDE) study for POLARxTM.

In addition, in the third quarter of 2021, we completed the acquisition of Farapulse, Inc. (Farapulse), a privately-held company that has developed a Pulsed Field Ablation (PFA) System - a non-thermal single-shot ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias.

Farapulse became the first company to commercialize a cardiac PFA technology after receiving CE Mark in Europe in the first quarter of 2021.

- AVVIGO™ Guidance Systems and AVVIGO™ Guidance System II, incorporating high-definition IVUS all in a mobile or integrated platform, and

Our next-generation AVVIGO™ Guidance System II is a streamlined multi-modality guidance system platform that features intuitive software for an easy workflow and specialized tools for IVUS and coronary physiology.

- SENTINEL™ Cerebral Embolic Protection Systems.

During 2021, we completed the full U.S. launch and transition to the next-generation WATCHMAN FLX LAAC Device, designed to advance procedural performance and safety while expanding the treatable patient population.

In the first quarter of 2021, we received approval from Japan's Ministry of Health, Labor and Welfare (MHLW) for the Ranger™ Drug-Coated Balloon and initiated a full launch.

In the fourth quarter of 2021, we completed our acquisition of Devoro Medical Inc., developer of the WOLF Thrombectomy® Platform, an innovative non-console and lytic-free technology which rapidly captures and removes blood clots, complementing our full suite of interventional strategies for thromboemboli in the arterial and venous systems.

In the first quarter of 2021, we received FDA approval for our TheraSphere™ Y-90 radioactive glass microspheres for the treatment of HCC after 20 years as a humanitarian exemption (HDE) device and secured FDA Breakthrough Device designation for TheraSphere treatment for patients with glioblastoma, an aggressive form of brain cancer.

On March 1, 2021, we completed the divestiture of the Specialty Pharmaceuticals business for a purchase price of approximately $800 million.

Our consolidated net sales include Specialty Pharmaceuticals up to the date of the closing of the transaction.

Markets

In 2021, approximately 50

Resources

We have an ongoing supplier resiliency program which identifies and mitigates risk and have taken measures to mitigate the impact of challenges within the global supply chain resulting from the COVID-19 pandemic.

We have recently experienced increased levels of unpredictability in the supply of certain raw materials and components used in the manufacturing of our products.

While we continue to believe we will have access to the raw materials and components that we need, these supply chain dynamics could result in increased costs to us or an inability to fully meet customer demand for certain of our products.

On an on-going basis, we track supplier status and inventory in risk areas and take action to prevent shortages, monitoring safety stock levels and building up product supplies as warranted, and mitigating risk of technology and material shortages by identifying new vendors.

Our approach to supplier selection involves building diversity, equity and inclusion throughout the Boston Scientific supplier network.

As part of our strategy to combat racism, we have taken steps to further expand the number of Black-owned enterprises that provide supply chain services for our business in the U.S. We are also supporting small and diverse vendors by shortening payment terms for those whose business with us is under $250,000.

The absence

Regulatory Environment

The CE mark continues to be a prerequisite for successful registration in many other global geographies.

Regulatory requirements are becoming more stringent, with the China National Medical Product Administration (NMPA) recently increasing the regulatory requirements to market and maintain products in China, and the introduction of such regulatory requirements in many countries in the Middle East and Southeast Asia that previously did not have medical device regulations, or had minimal regulations.

As a result of the United Kingdom's departure from the European Union (EU), we also

expect a U.K. Regulation to be implemented beginning July 2023, with requirements to sell in the U.K. already in place including appointment of a U.K. Responsible Person and device registration with The Medicines and Healthcare products Regulatory Agency (MHRA).

In addition, other EU countries continue to impose significant local registration requirements despite the implementation of MDR.

Although we believe our less-invasive products and technologies generate favorable clinical outcomes, value and cost efficiency, the resources necessary to

The current U.S. Administration may support the introduction of healthcare legislation, or take regulatory action, that could lead to significant changes to Medicare's reimbursement practices defined in the inpatient prospective payment system, outpatient prospective payment system, ambulatory surgical center, and/or Physician Fee Schedule rules.

Our approach to innovation combines internally-developed products and technologies with those we may obtain externally through strategic acquisitions, alliances and other investments.

- our SpaceOAR™ Hydrogel System, purchased as part of the Augmenix, Inc. (Augmenix) acquisition in the fourth quarter of 2018, to help reduce side effects that men may experience after receiving radiotherapy to treat prostate cancer, and

In the third quarter of 2020, we initiated the U.S. launch of the next-generation SpaceOAR Vue™ Hydrogel, providing clinicians with the added ability to view the spacer using computerized tomography (CT) scans instead of magnetic resonance imaging (MRI).

We began U.S. commercialization of this device in the third quarter of 2020.

In addition, in January 2021, we announced entry into a definitive agreement to acquire Preventice Solutions, Inc., a privately-held company that offers a full portfolio of mobile health solutions and remote monitoring services for patients with cardiac arrhythmias.

Refer to *Note B – Acquisitions and Strategic Investments* for additional information.

In June 2020, we announced the U.S. launch of the DIRECTSENSE™ Technology, for which we received CE Mark and launched in Europe in 2018, a tool for monitoring radiofrequency (RF) energy delivery during cardiac ablation procedures available on the Rhythmia™ Mapping System.

Additionally, in the second quarter of 2020 we received CE mark approval for the INTELLANAV STABLEPOINT™ Ablation Catheter enabled with DIRECTSENSE Technology and contact force

assessment.

This technology, along with our 2020 CE mark approval for the POLARx™ Cryoablation System, began European commercialization in the third quarter of 2020.

We also offer our IntellaNav XP and IntellaNav MiFi XP solid tip catheters.

Our IntellaTip™ MiFi XP, IntellaNav MiFi XP and IntellaNav MiFi Open-Irrigated Catheters include MicroFidelity (MiFi) sensor technology in the catheter tip.

Additionally, the European and Japan markets have access to our DIRECTSENSE™ Software which captures and presents local impedance.

We also received CE Mark in early 2020 for our POLARx Cryoablation Single-shot Pulmonary Vein Isolation Technology, purchased as part of our acquisition of Cryterion in the third quarter of 2018.

In 2020, we began our European launch and we commenced enrollment of the FROZEN-AF investigational device exemption (IDE) in the U.S.

- our Promus PREMIER™ Everolimus-Eluting family of stents, and

- our SYNERGY MEGATRON™ Bioabsorbable Polymer Stent.

- our SENTINEL™ Cerebral Embolic Protection System, purchased as part of our acquisition of Claret Medical, Inc. (Claret) in the third quarter of 2018.

In the first quarter of 2019, we received CE Mark and initiated a limited market release of the next generation WATCHMAN FLX™ LAAC Device in Europe and in June 2020, we received FDA approval for and launched WATCHMAN FLX LAAC Device in the U.S. Throughout 2020, the WATCHMAN Device was the only LAAC technology commercially available in the U.S.

In the fourth quarter of 2020, we announced a voluntary recall of our LOTUS Edge™ Aortic Value System and the discontinuation of our LOTUS program due to complexities associated with the product delivery system, and the time and investment required to reintroduce an enhanced delivery system, as well as slower than anticipated market adoption.

We will instead focus our resources and efforts on the remainder of the portfolio and are encouraged by the successful launch of ACURATE neo2 Valve in Europe.

In addition, through our acquisition of Millipede, Inc. in the first quarter of 2019, we are developing the IRIS Transcatheter Annuloplasty Ring System for the treatment of severe mitral regurgitation (MR).

The Millipede IRIS annuloplasty ring, delivered via a transcatheter-transseptal delivery system, follows the standard surgical approach to repair and reduce the size of a dilated mitral annulus.

The IRIS device is a complete ring designed to be used as a stand-alone device, or in combination with other technologies in patients with severe MR. The device is designed to be highly customizable to a specific patient's anatomy and disease state, and is repositionable and retrievable to promote a high-quality outcome.

- our AngioJet Zelante DVT™ Thrombectomy Catheter to treat deep vein thrombosis (DVT) in large-diameter upper and lower limb peripheral veins, in the U.S. and Europe,

- our VICI VENOUS STENT™ System to treat venous obstructive disease, purchased as part of the VENITI, Inc. acquisition in the third quarter of 2018,

Following the closing of our BTG acquisition, we have presented the Specialty Pharmaceuticals business as a standalone operating segment alongside our reportable segments.

Our Specialty Pharmaceuticals business develops and manufactures acute care antidotes to treat overexposure to certain medications and toxins.

These products are sold primarily in the U.S. through small, specialist sales teams and through commercial partners elsewhere, where approved or permitted.

Our Specialty Pharmaceuticals product offerings include the following:

- our CroFab™ Antidote Product, the only FDA-approved product derived exclusively from U.S. snakes and approved to treat all North American pit viper envenomations in adult and pediatric patients,

- our DigiFab™ Digoxin Immune Fab (Ovine) antidote product, a treatment for patients with life-threatening or potentially life-threatening digoxin toxicity or overdose that is clinically proven to effectively clear digoxin from the body, and

- our Voraxaze™ Antidote Product, a carboxypeptidase indicated to reduce toxic plasma methotrexate concentration (greater than one micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than two standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function.

On December 1, 2020, we announced the execution of a definitive agreement pursuant to which we agreed to sell our Specialty Pharmaceuticals business for a purchase price of $800 million, subject to certain adjustments, including cash on hand at the closing date of the transaction.

The transaction is expected to close during the first half of 2021, subject to customary closing conditions.

optimizing our cost structure, which we believe will enable increased development activity and faster concept-to-market timelines.

International net sales accounted for 42 percent of our net sales in 2020 and 2019 and 44 percent of our net sales in 2018.

In addition, we continue to invest in infrastructure in emerging markets to strengthen our sales and service capabilities and maximize our opportunities in these countries.

Our international manufacturing facilities includes our Puerto Rico facility.

We also maintain research and development capabilities in China, Costa Rica, India, Ireland and Puerto Rico.

Financial Statements and Supplementary Data of this Annual Report [removed: and] [added: on Form 10-Kand] incorporated herein by reference.

For the fiscal year ended December 31, [removed: 2020][added: 2021]

The aggregate market value of the registrant’s common stock held by non-affiliates was approximately [removed: $50.0] [added: $60.6] billion based on the last reported sale price of [removed: $35.11] [added: $42.76] of the registrant’s common stock on the New York Stock Exchange on June 30, [removed: 2020,] [added: 2021,] the last business day of the registrant’s most recently completed second fiscal quarter.

The number of shares outstanding of Common Stock, $0.01 par value per share, as of January [removed: 29, 2021] [added: 31, 2022] was [removed: 1,417,165,707.][added: 1,426,724,712.]

Portions of the registrant’s definitive proxy statement to be filed within 120 days of December 31, [removed: 2020] [added: 2021] with the Securities and Exchange Commission in connection with its [removed: 2021] [added: 2022] Annual Meeting of Stockholders are incorporated by reference into Part III of this Form 10-K.

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| [ITEM [removed: 5.](#i5c3e8d69fcc1460baddde62cfa022487_37)] [added: 5.](#i4513a36fb1aa4e44acd87206b0aed737_37)] | | | [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#i5c3e8d69fcc1460baddde62cfa022487_37)] [added: SECURITIES](#i4513a36fb1aa4e44acd87206b0aed737_37)] | | | [removed: [38](#i5c3e8d69fcc1460baddde62cfa022487_37)] [added: [37](#i4513a36fb1aa4e44acd87206b0aed737_37)] | | |

| [ITEM [removed: 7.](#i5c3e8d69fcc1460baddde62cfa022487_43)] [added: 7.](#i4513a36fb1aa4e44acd87206b0aed737_43)] | | | [MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#i5c3e8d69fcc1460baddde62cfa022487_43)] [added: OPERATIONS](#i4513a36fb1aa4e44acd87206b0aed737_43)] | | | [removed: [41](#i5c3e8d69fcc1460baddde62cfa022487_43)] [added: [40](#i4513a36fb1aa4e44acd87206b0aed737_43)] | | |

| [ITEM [removed: 7A.](#i5c3e8d69fcc1460baddde62cfa022487_67)] [added: 7A.](#i4513a36fb1aa4e44acd87206b0aed737_67)] | | | [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#i5c3e8d69fcc1460baddde62cfa022487_67)] [added: RISK](#i4513a36fb1aa4e44acd87206b0aed737_67)] | | | [removed: [68](#i5c3e8d69fcc1460baddde62cfa022487_67)] [added: [67](#i4513a36fb1aa4e44acd87206b0aed737_67)] | | |

| [ITEM [removed: 8.](#i5c3e8d69fcc1460baddde62cfa022487_73)] [added: 8.](#i4513a36fb1aa4e44acd87206b0aed737_73)] | | | [FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#i5c3e8d69fcc1460baddde62cfa022487_73)] [added: DATA](#i4513a36fb1aa4e44acd87206b0aed737_73)] | | | [removed: [71](#i5c3e8d69fcc1460baddde62cfa022487_73)] [added: [70](#i4513a36fb1aa4e44acd87206b0aed737_73)] | | |

| [ITEM [removed: 9.](#i5c3e8d69fcc1460baddde62cfa022487_163)] [added: 9.](#i4513a36fb1aa4e44acd87206b0aed737_157)] | | | [CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#i5c3e8d69fcc1460baddde62cfa022487_163)] [added: DISCLOSURE](#i4513a36fb1aa4e44acd87206b0aed737_157)] | | | [removed: [137](#i5c3e8d69fcc1460baddde62cfa022487_163)] [added: [134](#i4513a36fb1aa4e44acd87206b0aed737_157)] | | |

| [ITEM [removed: 9A.](#i5c3e8d69fcc1460baddde62cfa022487_166)] [added: 9A.](#i4513a36fb1aa4e44acd87206b0aed737_160)] | | | [CONTROLS AND [removed: PROCEDURES](#i5c3e8d69fcc1460baddde62cfa022487_166)] [added: PROCEDURES](#i4513a36fb1aa4e44acd87206b0aed737_160)] | | | [removed: [137](#i5c3e8d69fcc1460baddde62cfa022487_166)] [added: [134](#i4513a36fb1aa4e44acd87206b0aed737_160)] | | |

| [ITEM [removed: 9B.](#i5c3e8d69fcc1460baddde62cfa022487_169)] [added: 9B.](#i4513a36fb1aa4e44acd87206b0aed737_163)] | | | [OTHER [removed: INFORMATION](#i5c3e8d69fcc1460baddde62cfa022487_169)] [added: INFORMATION](#i4513a36fb1aa4e44acd87206b0aed737_163)] | | | [removed: [137](#i5c3e8d69fcc1460baddde62cfa022487_169)] [added: [134](#i4513a36fb1aa4e44acd87206b0aed737_163)] | | |

| [ITEM [removed: 10.](#i5c3e8d69fcc1460baddde62cfa022487_175)] [added: 10.](#i4513a36fb1aa4e44acd87206b0aed737_169)] | | | [DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#i5c3e8d69fcc1460baddde62cfa022487_175)] [added: GOVERNANCE](#i4513a36fb1aa4e44acd87206b0aed737_169)] | | | [removed: [138](#i5c3e8d69fcc1460baddde62cfa022487_175)] [added: [135](#i4513a36fb1aa4e44acd87206b0aed737_169)] | | |

| [ITEM [removed: 11.](#i5c3e8d69fcc1460baddde62cfa022487_178)] [added: 11.](#i4513a36fb1aa4e44acd87206b0aed737_172)] | | | [EXECUTIVE [removed: COMPENSATION](#i5c3e8d69fcc1460baddde62cfa022487_178)] [added: COMPENSATION](#i4513a36fb1aa4e44acd87206b0aed737_172)] | | | [removed: [138](#i5c3e8d69fcc1460baddde62cfa022487_178)] [added: [135](#i4513a36fb1aa4e44acd87206b0aed737_172)] | | |

| [ITEM [removed: 12.](#i5c3e8d69fcc1460baddde62cfa022487_181)] [added: 12.](#i4513a36fb1aa4e44acd87206b0aed737_175)] | | | [SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#i5c3e8d69fcc1460baddde62cfa022487_181)] [added: MATTERS](#i4513a36fb1aa4e44acd87206b0aed737_175)] | | | [removed: [138](#i5c3e8d69fcc1460baddde62cfa022487_181)] [added: [135](#i4513a36fb1aa4e44acd87206b0aed737_175)] | | |

| [ITEM [removed: 13.](#i5c3e8d69fcc1460baddde62cfa022487_184)] [added: 13.](#i4513a36fb1aa4e44acd87206b0aed737_178)] | | | [CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR [removed: INDEPENDENCE](#i5c3e8d69fcc1460baddde62cfa022487_184)] [added: INDEPENDENCE](#i4513a36fb1aa4e44acd87206b0aed737_178)] | | | [removed: [138](#i5c3e8d69fcc1460baddde62cfa022487_184)] [added: [135](#i4513a36fb1aa4e44acd87206b0aed737_178)] | | |

| [ITEM [removed: 14.](#i5c3e8d69fcc1460baddde62cfa022487_187)] [added: 14.](#i4513a36fb1aa4e44acd87206b0aed737_181)] | | | [PRINCIPAL ACCOUNTANT FEES AND [removed: SERVICES](#i5c3e8d69fcc1460baddde62cfa022487_187)] [added: SERVICES](#i4513a36fb1aa4e44acd87206b0aed737_181)] | | | [removed: [138](#i5c3e8d69fcc1460baddde62cfa022487_187)] [added: [135](#i4513a36fb1aa4e44acd87206b0aed737_181)] | | |

| [ITEM [removed: 15.](#i5c3e8d69fcc1460baddde62cfa022487_193)] [added: 15.](#i4513a36fb1aa4e44acd87206b0aed737_187)] | | | [EXHIBITS AND FINANCIAL STATEMENT [removed: SCHEDULES](#i5c3e8d69fcc1460baddde62cfa022487_193)] [added: SCHEDULES](#i4513a36fb1aa4e44acd87206b0aed737_187)] | | | [removed: [139](#i5c3e8d69fcc1460baddde62cfa022487_193)] [added: [136](#i4513a36fb1aa4e44acd87206b0aed737_187)] | | |

| [removed: [](#i5c3e8d69fcc1460baddde62cfa022487_1976)[ITEM 16.](#i5c3e8d69fcc1460baddde62cfa022487_1976)] [added: [ITEM 16.](#i4513a36fb1aa4e44acd87206b0aed737_190)] | | | [FORM 10-K [removed: SUMMARY](#i5c3e8d69fcc1460baddde62cfa022487_1976)] [added: SUMMARY](#i4513a36fb1aa4e44acd87206b0aed737_190)] | | | [removed: [151](#i5c3e8d69fcc1460baddde62cfa022487_1976)] [added: [148](#i4513a36fb1aa4e44acd87206b0aed737_190)] | | |

| [PART I](#i4513a36fb1aa4e44acd87206b0aed737_13) | | | | | | [3](#i4513a36fb1aa4e44acd87206b0aed737_13) | | |

| [PART II](#i4513a36fb1aa4e44acd87206b0aed737_34) | | | | | | [37](#i4513a36fb1aa4e44acd87206b0aed737_34) | | |

| [ITEM 6.](#i4513a36fb1aa4e44acd87206b0aed737_40) | | | [RESERVED](#i4513a36fb1aa4e44acd87206b0aed737_40) | | | [39](#i4513a36fb1aa4e44acd87206b0aed737_40) | | |

| [ITEM 9C.](#i4513a36fb1aa4e44acd87206b0aed737_1944) | | | [DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS](#i4513a36fb1aa4e44acd87206b0aed737_1944) | | | [134](#i4513a36fb1aa4e44acd87206b0aed737_1944) | | |

| [PART III](#i4513a36fb1aa4e44acd87206b0aed737_166) | | | | | | [135](#i4513a36fb1aa4e44acd87206b0aed737_166) | | |

| [PART IV](#i4513a36fb1aa4e44acd87206b0aed737_184) | | | | | | [136](#i4513a36fb1aa4e44acd87206b0aed737_184) | | |

| [SIGNATURES](#i4513a36fb1aa4e44acd87206b0aed737_193) | | | | | | [149](#i4513a36fb1aa4e44acd87206b0aed737_193) | | |

| [PART I](#i5c3e8d69fcc1460baddde62cfa022487_13) | | | | | | [3](#i5c3e8d69fcc1460baddde62cfa022487_13) | | |

| [PART II](#i5c3e8d69fcc1460baddde62cfa022487_34) | | | | | | [38](#i5c3e8d69fcc1460baddde62cfa022487_34) | | |

| [ITEM 6.](#i5c3e8d69fcc1460baddde62cfa022487_40) | | | [SELECTED FINANCIAL DATA](#i5c3e8d69fcc1460baddde62cfa022487_40) | | | [40](#i5c3e8d69fcc1460baddde62cfa022487_40) | | |

| [PART III](#i5c3e8d69fcc1460baddde62cfa022487_172) | | | | | | [138](#i5c3e8d69fcc1460baddde62cfa022487_172) | | |

| [PART IV](#i5c3e8d69fcc1460baddde62cfa022487_190) | | | | | | [139](#i5c3e8d69fcc1460baddde62cfa022487_190) | | |

| [SIGNATURES](#i5c3e8d69fcc1460baddde62cfa022487_196) | | | | | | [152](#i5c3e8d69fcc1460baddde62cfa022487_196) | | |

Our world headquarters is located in [added: the U.S, in] Marlborough, Massachusetts, with principal regional headquarters located in Singapore and Voisins-le-Bretonneux, France.

As of December 31, [removed: 2020, our] [added: 2021, we maintained 16] principal manufacturing [removed: and technology centers were located] [added: facilities, including eight] in [removed: Minnesota, California and Indiana within] the [removed: U.S., as well as internationally] [added: U.S. and Puerto Rico, three] in Ireland, [added: two in] Costa Rica, [removed: Puerto Rico,] [added: one in] Malaysia, [added: one in] Brazil and [removed: Switzerland.][added: one in Switzerland, as well as various distribution and technology centers around the world.]

The following is a summary of our facilities as of December 31, [removed: 2020] [added: 2021] (in approximate square feet):

| U.S. | | | 4,043,041 | | | | | | 1,257,706 | | | | | | 5,300,747 | | |

| International | | | 2,200,042 | | | | | | 1,916,968 | | | | | | 4,117,010 | | |

| | | | 6,243,083 | | | | | | 3,174,674 | | | | | | 9,417,757 | | |

As of December 31, 2020, we maintained 16 principal manufacturing facilities, including seven in the U.S., three in Ireland, two in Costa Rica, one in Puerto Rico, one in Malaysia, one in Brazil and one in Switzerland, as well as various distribution and technology centers around the world.

| U.S. | | | 4,043,041 | | | | | | 1,319,960 | | | | | | 5,363,001 | | |

| International(3) | | | 2,200,044 | | | | | | 1,653,732 | | | | | | 3,853,776 | | |

| | | | 6,243,085 | | | | | | 2,973,692 | | | | | | 9,216,777 | | |

(3) International facilities includes Puerto Rico.

As of January [removed: 29, 2021,] [added: 31, 2022,] there were [removed: 6,943] [added: 6,226] holders of record of our common stock.

We did not pay a cash dividend in [removed: 2020, 2019] [added: 2021, 2020] or [removed: 2018] [added: 2019] on our common stock and currently we do not intend to pay cash dividends on our common stock.

"Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters" under Part III of this Annual Report [added: on Form 10-K] for information on where to find information required by Item 201(d) of Regulation S-K.

In [removed: the fourth quarter of] 2020, we repurchased approximately [added: $535 million or] 15.7 million shares of our common stock [removed: pursuant to our] [added: under the 2013] share repurchase [removed: authorization for a total of approximately $535 million in cash.][added: program, which represented the full amount remaining under that authorization.]

Refer to [removed: *Note] [added: Note] L – Stockholders' [removed: Equity*] [added: Equity] to our consolidated financial statements contained in Item 8.

Financial Statements and Supplementary Data of this Annual Report [added: on Form 10-K] for additional information.

[removed: (2)] On December 14, 2020, our Board of Directors approved, and we announced, a new stock repurchase program authorizing the repurchase of up to $1.000 billion of our common stock (2020 share repurchase program).

[removed: As] [added: We made no share repurchases in 2021 and, as] of December 31, [removed: 2020, we] [added: 2021,] had [added: the full] $1.000 billion remaining available under the 2020 share repurchase program.

The graph assumes $100 was invested in our common stock and in each of the named indices on December 31, [removed: 2015] [added: 2016] and that any dividends were reinvested.

[removed: ][added: ]

There were no purchases of equity securities by the issuer or affiliated purchases in the fourth quarter of 2021, required to be reported here.

We made no share repurchases in 2019 or 2018.

The following table provides information with respect to purchases by Boston Scientific Corporation of equity securities that are registered by us pursuant to Section 12 of the Exchange Act, during the fourth quarter of 2020:

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| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Period | | | Total Number of Shares Purchased | | | | | | Average Price Paid per Share(1) | | | | | | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs(2) | | | | | | Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs(2) | | |

| 10/1/20 - 10/31/20 | | | 0 | | | | | | $ | — | | | | | 0 | | | | | | $ | 534,535,954 | |

| 11/1/20 - 11/30/20 | | | 0 | | | | | | — | | | | | | 0 | | | | | | 534,535,954 | | |

| 12/1/20 - 12/31/20 | | | 15,723,578 | | | | | | 33.98 | | | | | | 15,723,578 | | | | | | 1,000,000,000 | | |

| Total | | | 15,723,578 | | | | | | $ | 33.98 | | | | | 15,723,578 | | | | | | $ | 1,000,000,000 | |

(1) Excludes any fees, commissions or other expenses related to such repurchases.

During the fourth quarter of 2020, we repurchased approximately $535 million of our common stock under the 2013 share repurchase program, which represented the full amount remaining under that authorization.

Not applicable.

FIVE-YEAR SELECTED FINANCIAL DATA

*(in millions, except per share data)*

Operating Data

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| Year Ended December 31, | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | | | | | | | |

| Net sales | | | $ | 9,913 | | | | | $ | 10,735 | | | | | $ | 9,823 | | | | | $ | 9,048 | | | | | $ | 8,386 | | | | | | | |

| Gross profit | | | 6,448 | | | | | | 7,620 | | | | | | 7,011 | | | | | | 6,455 | | | | | | 5,962 | | | | | | | | |

| Total operating expenses | | | 6,528 | | | | | | 6,102 | | | | | | 5,504 | | | | | | 5,170 | | | | | | 5,515 | | | | | | | | |

| Operating income (loss) | | | (80) | | | | | | 1,518 | | | | | | 1,506 | | | | | | 1,285 | | | | | | 447 | | | | | | | | |

| Income (loss) before income taxes | | | (79) | | | | | | 687 | | | | | | 1,422 | | | | | | 933 | | | | | | 177 | | | | | | | | |

| Net income (loss) | | | (82) | | | | | | 4,700 | | | | | | 1,671 | | | | | | 104 | | | | | | 347 | | | | | | | | |

| Net income (loss) available to common stockholders | | | (115) | | | | | | 4,700 | | | | | | 1,671 | | | | | | 104 | | | | | | 347 | | | | | | | | |

| Net income (loss) per common share: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Basic | | | $ | (0.08) | | | | | $ | 3.38 | | | | | $ | 1.21 | | | | | $ | 0.08 | | | | | $ | 0.26 | | | | | | | |

| Assuming dilution | | | $ | (0.08) | | | | | $ | 3.33 | | | | | $ | 1.19 | | | | | $ | 0.08 | | | | | $ | 0.25 | | | | | | | |

Balance Sheet Data

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| As of December 31, | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | | | | | | | |

| Cash, cash equivalents and marketable securities | | | $ | 1,734 | | | | | $ | 217 | | | | | $ | 146 | | | | | $ | 188 | | | | | $ | 196 | | | | | | | |

| Working capital (deficit) | | | 3,013 | | | | | | (168) | | | | | | (1,257) | | | | | | (1,832) | | | | | | (348) | | | | | | | | |

| Total assets | | | 30,777 | | | | | | 30,565 | | | | | | 20,999 | | | | | | 19,042 | | | | | | 18,096 | | | | | | | | |

| Borrowings (short-term) | | | 13 | | | | | | 1,416 | | | | | | 2,253 | | | | | | 1,801 | | | | | | 64 | | | | | | | | |

| Borrowings (long-term) | | | 9,130 | | | | | | 8,592 | | | | | | 4,803 | | | | | | 3,815 | | | | | | 5,420 | | | | | | | | |

| Stockholders’ equity | | | 15,326 | | | | | | 13,877 | | | | | | 8,726 | | | | | | 7,012 | | | | | | 6,733 | | | | | | | | |

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The data above should be read in conjunction with our consolidated financial statements, including the notes thereto, included in Item 8.

Financial Statements and Supplementary Data of our Annual Report on Form 10-K.

| *(in millions, except per share data)* | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |

| Net sales | | | $ | [removed: 9,913] [added: 11,888] | | | | | $ | [removed: 10,735] [added: 9,913] | | | | | $ | [removed: 9,823] [added: 10,735] | |

| Cost of products sold | | | [removed: 3,465] [added: 3,711] | | | | | | [removed: 3,116] [added: 3,465] | | | | | | [removed: 2,813] [added: 3,116] | | |

| Gross profit | | | [removed: 6,448] [added: 8,177] | | | | | | [removed: 7,620] [added: 6,448] | | | | | | [removed: 7,011] [added: 7,620] | | |

| Selling, general and administrative expenses | | | [removed: 3,787] [added: 4,359] | | | | | | [removed: 3,941] [added: 3,787] | | | | | | [removed: 3,569] [added: 3,941] | | |

| Research and development expenses | | | [removed: 1,143] [added: 1,204] | | | | | | [removed: 1,174] [added: 1,143] | | | | | | [removed: 1,113] [added: 1,174] | | |

| Royalty expense | | | [removed: 45] [added: 49] | | | | | | [removed: 65] [added: 45] | | | | | | [removed: 70] [added: 65] | | |

| Amortization expense | | | [removed: 789] [added: 741] | | | | | | [removed: 699] [added: 789] | | | | | | [removed: 599] [added: 699] | | |

| Goodwill impairment charges | | | [removed: 73] [added: —] | | | | | | [removed: —] [added: 73] | | | | | | — | | |

| Intangible asset impairment charges | | | [removed: 460] [added: 370] | | | | | | [removed: 105] [added: 460] | | | | | | [removed: 35] [added: 105] | | |

| Contingent consideration net expense (benefit) | | | [removed: (100)] [added: (136)] | | | | | | [removed: (35)] [added: (100)] | | | | | | [removed: (21)] [added: (35)] | | |

| Restructuring net charges (credits) | | | [removed: 52] [added: 40] | | | | | | [removed: 38] [added: 52] | | | | | | [removed: 36] [added: 38] | | |

| Litigation-related net charges (credits) | | | [removed: 278] [added: 430] | | | | | | [removed: 115] [added: 278] | | | | | | [removed: 103] [added: 115] | | |

| | | | [removed: 6,528] [added: 6,978] | | | | | | [removed: 6,102] [added: 6,528] | | | | | | [removed: 5,504] [added: 6,102] | | |

| Operating income (loss) | | | [removed: (80)] [added: 1,199] | | | | | | [removed: 1,518] [added: (80)] | | | | | | [removed: 1,506] [added: 1,518] | | |

| Interest expense | | | [removed: (361)] [added: (341)] | | | | | | [removed: (473)] [added: (361)] | | | | | | [removed: (241)] [added: (473)] | | |

| Other, net | | | [removed: 362] [added: 218] | | | | | | [removed: (358)] [added: 362] | | | | | | [removed: 156] [added: (358)] | | |

| Income (loss) before income taxes | | | [removed: (79)] [added: 1,076] | | | | | | [removed: 687] [added: (79)] | | | | | | [removed: 1,422] [added: 687] | | |

| Income tax (benefit) expense | | | [removed: 2] [added: 36] | | | | | | [removed: (4,013)] [added: 2] | | | | | | [removed: (249)] [added: (4,013)] | | |

| Net income (loss) | | | [removed: (82)] [added: 1,041] | | | | | | [removed: 4,700] [added: (82)] | | | | | | [removed: 1,671] [added: 4,700] | | |

| Preferred stock dividends | | | [removed: (33)] [added: (55)] | | | | | | [removed: —] [added: (33)] | | | | | | — | | |

| Net income (loss) available to common stockholders | | | $ | [removed: (115)] [added: 985] | | | | | $ | [removed: 4,700] [added: (115)] | | | | | $ | [removed: 1,671] [added: 4,700] | |

| Net income (loss) per common share — basic | | | $ | [removed: (0.08)] [added: 0.69] | | | | | $ | [removed: 3.38] [added: (0.08)] | | | | | $ | [removed: 1.21] [added: 3.38] | |

| Net income (loss) per common share — assuming dilution | | | $ | [removed: (0.08)] [added: 0.69] | | | | | $ | [removed: 3.33] [added: (0.08)] | | | | | $ | [removed: 1.19] [added: 3.33] | |

| Basic | | | [removed: 1,416.7] [added: 1,422.3] | | | | | | [removed: 1,391.5] [added: 1,416.7] | | | | | | [removed: 1,381.0] [added: 1,391.5] | | |

| Assuming dilution | | | [removed: 1,416.7] [added: 1,433.8] | | | | | | [removed: 1,410.6] [added: 1,416.7] | | | | | | [removed: 1,401.4] [added: 1,410.6] | | |

| *(in millions)* | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |

| Net income (loss) | | | $ | [removed: (82)] [added: 1,041] | | | | | $ | [removed: 4,700] [added: (82)] | | | | | $ | [removed: 1,671] [added: 4,700] | |

| Foreign currency translation adjustment | | | [removed: 76] [added: (125)] | | | | | | [removed: 195] [added: 76] | | | | | | [removed: (21)] [added: 195] | | |

| Net change in derivative financial instruments | | | [removed: (137)] [added: 170] | | | | | | [removed: 62] [added: (137)] | | | | | | [removed: 110] [added: 62] | | |

| Net change in defined benefit pensions and other items | | | [removed: (1)] [added: 11] | | | | | | [removed: (20)] [added: (1)] | | | | | | [removed: 2] [added: (20)] | | |

| Total other comprehensive income (loss) | | | [removed: (63)] [added: 56] | | | | | | [removed: 237] [added: (63)] | | | | | | [removed: 91] [added: 237] | | |

| Total comprehensive income (loss) | | | $ | [removed: (145)] [added: 1,096] | | | | | $ | [removed: 4,937] [added: (145)] | | | | | $ | [removed: 1,761] [added: 4,937] | |

| *(in millions, except share and per share data)* | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| [removed: Cash] [added: *Cash] and cash [removed: equivalents] [added: equivalents*] | | | $ | [added: 1,925 | | | | | $ |] 1,734 | | | | | $ | 217 | |

| Trade accounts receivable, net | | | [removed: 1,531] [added: 1,778] | | | | | | [removed: 1,828] [added: 1,531] | | |

| Inventories | | | [removed: 1,351] [added: 1,610] | | | | | | [removed: 1,579] [added: 1,351] | | |

| Prepaid income taxes | | | [removed: 194] [added: 205] | | | | | | [removed: 195] [added: 194] | | |

| Assets held for sale | | | [removed: 1,133] [added: —] | | | | | | [removed: —] [added: 1,133] | | |

| Other current assets | | | [removed: 751] [added: 799] | | | | | | [removed: 880] [added: 751] | | |

| Gains on disposal of businesses and assets | | | (78) | | | | | | — | | | | | | — | | |

| Total stockholders’ equity | | | 16,622 | | | | | | 15,326 | | |

| Preferred stock shares outstanding | | | | | | | | | | | | | | | | | |

| Beginning | | | 10,062,500 | | | | | | — | | | | | | — | | |

| Ending | | | 10,062,500 | | | | | | 10,062,500 | | | | | | — | | |

| Common stock shares outstanding | | | | | | | | | | | | | | | | | |

| Beginning | | | 1,679,911,918 | | | | | | 1,642,488,911 | | | | | | 1,632,148,030 | | |

| Ending | | | 1,688,810,052 | | | | | | 1,679,911,918 | | | | | | 1,642,488,911 | | |

| Beginning | | | $ | — | | | | | $ | — | | | | | $ | — | |

| Preferred stock issuance | | | — | | | | | | — | | | | | | — | | |

| Ending | | | — | | | | | | $ | — | | | | | — | | |

| Common stock | | | | | | | | | | | | | | | | | |

| Beginning | | | $ | 17 | | | | | $ | 16 | | | | | $ | 16 | |

| Common stock issuance | | | — | | | | | | — | | | | | | — | | |

| Ending | | | $ | 17 | | | | | $ | 17 | | | | | $ | 16 | |

| Treasury Stock | | | | | | | | | | | | | | | | | |

| Beginning | | | $ | (2,251) | | | | | $ | (1,717) | | | | | $ | (1,717) | |

| Ending | | | $ | (2,251) | | | | | $ | (2,251) | | | | | $ | (1,717) | |

| Additional Paid-In Capital | | | | | | | | | | | | | | | | | |

| Beginning | | | $ | 19,732 | | | | | $ | 17,561 | | | | | $ | 17,346 | |

| Preferred stock issuance | | | — | | | | | | 975 | | | | | | — | | |

| Common stock issuance | | | — | | | | | | 975 | | | | | | — | | |

| Ending | | | $ | 19,986 | | | | | $ | 19,732 | | | | | $ | 17,561 | |

| Accumulated Deficit | | | | | | | | | | | | | | | | | |

| Beginning | | | $ | (2,378) | | | | | $ | (2,253) | | | | | $ | (6,953) | |

| Ending | | | $ | (1,392) | | | | | $ | (2,378) | | | | | $ | (2,253) | |

| Beginning | | | $ | 207 | | | | | $ | 270 | | | | | $ | 33 | |

| Ending | | | $ | 263 | | | | | $ | 207 | | | | | $ | 270 | |

| Gain on disposal of businesses and assets | | | (78) | | | | | | — | | | | | | — | | |

| Other assets | | | (134) | | | | | | (265) | | | | | | 45 | | |

| Proceeds from sale of property, plant and equipment | | | 14 | | | | | | 12 | | | | | | 7 | | |

liability equal to these estimated costs as cost of products sold at the time the product sale occurs.

In cases where we acquire a company in which we previously held an equity stake, we attribute a portion of the purchase price to the previously-held equity interest, which is implied based on the total purchase consideration allocable to each of the shareholders, including Boston Scientific, according to priority of equity interests.

We record a gain or loss in *Other, net* equal to the difference between the implied fair value of our prior ownership and the book value immediately prior to the acquisition.

impairment, or more frequently if impairment indicators are present or changes in circumstances suggest an impairment may exist.

for tax on Global Intangible Low Taxed Income (GILTI) earned by certain foreign subsidiaries.

On February 14, 2022, we completed our acquisition of Baylis Medical Company Inc. (Baylis Medical), a privately-held company which has developed the radiofrequency (RF) NRG™ and VersaCross™ Transseptal Platforms as well as a family of guidewires, sheaths and dilators used to support left heart access, which will expand our electrophysiology and structural heart product portfolios.

The transaction consisted of an upfront cash payment using cash on hand of $1.750 billion subject to closing adjustments.

We plan to integrate the Baylis Medical business into our Electrophysiology division, supported by our structural heart sales force.

The transaction consisted of an upfront cash payment of $925 million and up to an additional $300 million in a potential commercial milestone payment.

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| | | | As of December 31, | | | | | | | | |

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| *(in millions, except share data)* | | | Shares Issued | | | | | | Par Value | | | | | | Shares Issued | | | | | | Par Value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| As of December 31, 2017 | | | — | | | | | | $ | — | | | | | 1,621,062,898 | | | | | | $ | 16 | | | | | $ | (1,717) | | | | | $ | 17,161 | | | | | | | | $ | (8,390) | | | | | $ | (59) | |

| Cumulative effect adjustments for ASC Update Adoptions(1) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (233) | | | | | | | | |

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| As of December 31, 2018 | | | — | | | | | | $ | — | | | | | 1,632,148,030 | | | | | | $ | 16 | | | | | $ | (1,717) | | | | | $ | 17,346 | | | | | | | | $ | (6,953) | | | | | $ | 33 | |

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| Foreign currency translation adjustment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 195 | | |

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| Defined benefit pensions and other items | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (20) | | |

| As of December 31, 2019 | | | — | | | | | | $ | — | | | | | 1,642,488,911 | | | | | | $ | 16 | | | | | $ | (1,717) | | | | | $ | 17,561 | | | | | | | | $ | (2,253) | | | | | $ | 270 | |

| Net income (loss) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (82) | | | | | | | | |

| Changes in other comprehensive income (loss), net of tax: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Foreign currency translation adjustment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 76 | | |

| Derivative financial instruments | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (137) | | |

| Defined benefit pensions and other items | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (1) | | |

| As of December 31, 2020 | | | 10,062,500 | | | | | | $ | — | | | | | 1,679,911,918 | | | | | | $ | 17 | | | | | $ | (2,251) | | | | | $ | 19,732 | | | | | | | | $ | (2,378) | | | | | $ | 207 | |

(1) In 2018, we recorded cumulative effect adjustments to retained earnings to reflect the adoption of Accounting Standards Codification (ASC) Update No. 2014-09, Update No. 2016-16 and Update No. 2016-01.

Our management, with the participation of our Chief Executive Officer (CEO) and Executive Vice President and Chief Financial Officer (CFO), evaluated the effectiveness of our disclosure controls and procedures as of December 31, [removed: 2020] [added: 2021] pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended.

Based on their evaluation, our CEO and CFO concluded that as of December 31, [removed: 2020,] [added: 2021,] our disclosure controls and procedures were effective.

Management’s annual report on our internal control over financial reporting is contained in Item 7 of this Annual [removed: Report.][added: Report on Form 10-K.]

The report of Ernst & Young LLP on our internal control over financial reporting is contained in Item 7 of this Annual [removed: Report.][added: Report on Form 10-K.]

During the quarter ended December 31, [removed: 2020,] [added: 2021,] there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

During 2022, we will begin a multi-year implementation of a new global enterprise resource planning (ERP) system, which will replace our existing system.

The implementation is expected to occur in phases over the next several years.

As the phased implementation occurs, it may result in changes to our processes and procedures which may result in changes to our internal controls over financial reporting.

As such changes occur, we will evaluate quarterly whether they materially affect our internal control over financial reporting.

PART III

Not applicable.

PART III

The information required by this Item is set forth in our Proxy Statement for the [removed: 2021] [added: 2022] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2020] [added: 2021] and is incorporated into this Annual Report [added: on Form 10-K] by reference.

The information required by this Item is set forth in our Proxy Statement for the [removed: 2021] [added: 2022] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2020] [added: 2021] and is incorporated into this Annual Report [added: on Form 10-K] by reference.

The information required by this Item is set forth in our Proxy Statement for the [removed: 2021] [added: 2022] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2020] [added: 2021] and is incorporated into this Annual Report [added: on Form 10-K] by reference.

The information required by this Item is set forth in our Proxy Statement for the [removed: 2021] [added: 2022] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2020] [added: 2021] and is incorporated into this Annual Report [added: on Form 10-K] by reference.

The information required by this Item is set forth in our Proxy Statement for the [removed: 2021] [added: 2022] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2020] [added: 2021] and is incorporated into this Annual Report [added: on Form 10-K] by reference.

Our independent registered public accounting firm is Ernst & Young LLP, New York, NY, (PCAOB ID 42).

| 4.2* | | | | | | [Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/885725/000088572521000008/exhibit42-descriptionofthe.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit42-descriptionofthe.htm)] | | |

| 10.131 | | | | | | [Boston Scientific Corporation 2021 Annual Bonus Plan, effective as of January 1, 2021 (incorporated herein by reference to Exhibit 10.1, Current Report on Form 8-K [removed: filed](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1012021annualbo.htm) [November] [added: filed November] 24, [removed: 2020](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1012021annualbo.htm)[,] [added: 2020,] File No. 001-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1012021annualbo.htm) | | |

| 10.133 | | | | | | [Boston Scientific Corporation 2021 Free Cash Flow Performance Share [removed: Program](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1032021freecash.htm) [(incorporated] [added: Program (incorporated] herein by reference to Exhibit 10.3, Current Report on Form [removed: 8-K](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1032021freecash.htm) [filed November](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1032021freecash.htm) [2](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1032021freecash.htm)[4,] [added: 8-K filed November 24,] 2020, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1032021freecash.htm) | | |

| 21* | | | | | | [List [removed: of the Boston] [added: of](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit21-listofsubsidiari.htm) [Boston] Scientific's subsidiaries as of January 31, [removed: 2021.](https://www.sec.gov/Archives/edgar/data/885725/000088572521000008/exhibit21-listofsubsidiari.htm)] [added: 202](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit21-listofsubsidiari.htm)[2](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit21-listofsubsidiari.htm)[.](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit21-listofsubsidiari.htm)] | | |

| 23* | | | | | | [Consent of Independent Registered Public Accounting Firm, Ernst & Young [removed: LLP.](https://www.sec.gov/Archives/edgar/data/885725/000088572521000008/exhibit23-2020eyconsent.htm)] [added: LLP.](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit23-2021eyconsent.htm)] | | |

| 31.1* | | | | | | [Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/885725/000088572521000008/exhibit311-ceo302202010xk.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit311-ceo302202110xk.htm)] | | |

| 31.2* | | | | | | [Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/885725/000088572521000008/exhibit312-cfo302202010xk.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit312-cfo302202110xk.htm)] | | |

| 32.1* | | | | | | [Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/885725/000088572521000008/exhibit321-ceo906202010xk.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit321-ceo906202110xk.htm)] | | |

| 32.2* | | | | | | [Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/885725/000088572521000008/exhibit322-cfo906202010xk.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit322-cfo906202110xk.htm)] | | |

| 4.24 | | | | | | [Second Supplemental Indenture dated as of April 21, 2006 between Boston Scientific Corporation and The Bank of New York Mellon Trust Company, N.A., as successor to J.P. Morgan Trust Company, National Association, as Trustee (incorporated herein by reference to Exhibit 99.6, Current Report on Form 8-K dated April 21, 2006, File No. 1-11083)](http://www.sec.gov/Archives/edgar/data/0000885725/000110465906027974/a06-8189_48k.htm) | | |

| 10.134 | | | | | | [Credit Agreement, dated as of May 10, 2021, by and among Boston Scientific Corporation, the lenders party thereto and Wells Fargo Bank, National Association, as administrative agent (incorporated herein by reference to Exhibit 10.1, Current Report on Form 8-K dated May 13, 2021, File No. 1-11083)](http://www.sec.gov/Archives/edgar/data/0000885725/000110465921065917/tm2116033d1_ex10-1.htm) | | |

| 10.135 | | | | | | [Boston Scientific Corporation 2022 Annual Bonus Plan, effective as of January 1, 2022 (incorporated herein by reference to Exhibit 10.1, Current Report on Form 8-K filed November 23, 2021, File No. 001-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572521000056/exhibit101bostonscientific.htm) | | |

| 10.136 | | | | | | [Boston Scientific Corporation 2022 Total Shareholder Return Performance Share Program (incorporated herein by reference to Exhibit 10.1, Current Report on Form 8-K filed November 23, 2021, File No. 001-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572521000056/exhibit102bostonscientific.htm) | | |

| 10.137 | | | | | | [Boston Scientific Corporation 2022 Free Cash Flow Performance Share Program (incorporated herein by reference to Exhibit 10.1, Current Report on Form 8-K filed November 23, 2021, File No. 001-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572521000056/exhibit103bostonscientific.htm) | | |

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| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | Boston Scientific Corporation | | | | | | | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ Daniel J. Brennan | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ Michael F. Mahoney | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ Jonathan R. Monson | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ Nelda J. Connors | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ Charles J. Dockendorff | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ Yoshiaki Fujimori | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ Donna A. James | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ Edward J. Ludwig | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ David J. Roux | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ John E. Sununu | | |

| Dated: February 23, [removed: 2021] [added: 2022] | | | | | | By: | | | | | | /s/ Ellen M. Zane | | |

| Description | | | Balance at Beginning of Year | | | | | | Cumulative effect adjustment for adoption of ASU 2016-13 (a) | | | | | | Credit loss exposure (a) | | | | | | Write-offs (c) | | | | | | [removed: Charges to (Deductions from) Other Accounts (d)] | | | | | | Balance at End of Year | | |

| Allowances for credit losses (b) | | | $ | 74 | | | | | 10 | | | | | | 49 | | | | | | (27) | | | | | | [removed: —] | | | | | | $ | 105 | |

| Allowances for uncollectible accounts | | | $ | 68 | | | | | n/a | | | | | | 23 | | | | | | (17) | | | | | | [removed: —] | | | | | | $ | 74 | |

| Year Ended December 31, [removed: 2018:] [added: 2021:] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Dated: February 23, 2022 | | | | | | By: | | | | | | /s/ David S. Wichmann | | |

| | | | | | | | | | | | | David S. Wichmann | | |

| Allowances for credit losses | | | $ | 105 | | | | | n/a | | | | | | 28 | | | | | | (25) | | | | | | | | | | | | $ | 108 | |

| Dated: February 23, 2021 | | | | | | By: | | | | | | /s/ Stephen P. MacMillan | | |

| | | | | | | | | | | | | Stephen P. MacMillan | | |

| Allowances for uncollectible accounts (e) | | | $ | 98 | | | | | n/a | | | | | | 19 | | | | | | (19) | | | | | | (30) | | | | | | $ | 68 | |

(d) Represents net change in allowances for sales returns, recorded as contra-revenue.

(e) Following the adoption of FASB ASC Topic 606 as of January 1, 2018, the allowance for sales returns has been reclassified from *Trade accounts receivable, net* to *Other current liabilities* within the consolidated balance sheets and is not included in the ending balance for 2018 above.

Prior period balances remain unchanged.